Addition of P1101 to Imatinib Treatment in Patients With Chronic Phase Chronic Myeloid Leukaemia Not Achieving a Complete Molecular Response

NCT01933906 | Completed Phase 1

• 2 other identifiers: AGMT_CML 12013-000115-24
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 4

Brief Summary

In this phase I pilot study, it is planned to investigate the feasibility and safety of adding an interferon therapy to an preexisting imatinib treatment in patients with chronic phase chronic myeloid leukaemia. The participating patients have already reached a response during their imatinib therapy (CCyR) but have still a detectable disease (no molecular response MR 4.5 or better).

Conditions

Chronic Phase Chronic Myeloid Leukemia

Keywords

CML; Chronic myeloid leukemia; Chronic myeloid leukaemia; PEG-Proline-Interferon-alpha 2b; Interferon; P1101; Imatinib

Outcome Measures

Primary Outcomes (1)

• Number and seriousness of adverse events to evaluate safety and tolerability

  The primary objective is to determine the safety and tolerability of the addition of P1101 to the pre-study established dose of imatinib.

  30 months

Secondary Outcomes (1)

• Efficacy (Number of patients achieving an improvement of remission status)

  30 months

Study Arms (1)

P1101

EXPERIMENTAL

P1101 50µg s.c. will be administered every 2 weeks in addition to preexisting imatinib treatment. In the absence of dose limiting toxicities after 12 weeks, the dose will be escalated to 100µg every 2 weeks. Maximum treatment duration will not expand 18 months.

Drug: P1101

Interventions

P1101 DRUG

Also known as: PEG-Proline-Interferon alpha-2b

P1101

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years of age
• BCR-ABL positive chronic myeloid leukaemia in chronic phase treated with imatinib as first line therapy
• CHR, CCyR after at least 18 months of imatinib treatment
• Adequate organ function, defined as the following:
• total bilirubin \< 1.5 x ULN,
• AST and ALT \< 2.5 x ULN,
• creatinine \< 1.5 x ULN,
• ANC \> 1.5 x 109/L,
• platelets \> 100 x 109/L
• Written, voluntarily signed informed consent

You may not qualify if:

• CMR (molecular remission 4.5 or BCR-ABL transcripts undetectable)
• Patient has received any other investigational treatment within 28 days before study entry
• Treatment with a second generation tyrosine kinase inhibitor (dasatinib, nilotinib)
• ECOG performance status ≥ 3
• Patients with a primary of a different histological origin than the study indication (unless relapse-free interval is ≥ 5 years, except cervical carcinoma, basal cell epithelioma or squamous cell carcinoma of the skin)
• Evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease etc.)
• Acute chronic infections
• Known autoimmune disease (e.g. collagen disease, polyarthritis, immune thrombocytopenia, thyroiditis, psoriasis, lupus nephritis or any other autoimmune disorder)
• Female patients who are pregnant or breast-feeding
• Known diagnosis of HIV

Sponsors & Collaborators

• Arbeitsgemeinschaft medikamentoese Tumortherapie: lead
• AOP Orphan Pharmaceuticals AG: collaborator

Study Sites (4)

Klinikum Wels-Grieskirchen GmbH, IV. Interne Abteilung

Wels, Upper Austria, 4600, Austria

Location

Universitätskliniken Innsbruck, Univ.-Klinik f.Innere Medizin V Hämtologie u. Onkologie

Innsbruck, A-6020, Austria

Location

Ordensklinikum Linz - Elisabethinen

Linz, A-4020, Austria

Location

Universitätsklinikum der PMU Salzburg, Universitätsklinik für Innere Medizin III

Salzburg, 5020, Austria

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Chronic-Phase; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

peginterferon alfa-2b

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Josef Thaler, MD

  Klinikum Wels-Grieskirchen GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2013
• First Posted: September 2, 2013
• Study Start: August 30, 2013
• Primary Completion: November 14, 2018
• Study Completion: November 14, 2018
• Last Updated: January 4, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)